Safety and efficacy of routine postoperative ibuprofen for pain and disability related to ectopic bone formation after hip replacement surgery (HIPAID): a randomised control trial

<b>Objectives </b>To determine the benefits and risks of a non-steroidal anti-inflammatory drug (NSAID) as prophylaxis for ectopic bone formation in patients undergoing total hip replacement (or revision) surgery.<br /><b>Design </b>Double blind randomised placebo controlled clinical trial, stratified by treatment site and surgery (primary or revision).<br /><b>Setting </b>20 orthopaedic surgery centres in Australia and New Zealand.<br /><b>Participants </b>902 patients undergoing elective primary or revision total hip replacement surgery.<br /><b>Intervention</b> 14 days' treatment with ibuprofen (1200 mg daily) or matching placebo started within 24 hours of surgery.<br /><b>Main outcome measures</b> Changes in self reported hip pain and physical function 6 to 12 months after surgery (Western Ontario and McMaster University Arthritis index).<br /><b>Results </b>There were no significant differences between the groups for improvements in hip pain (mean difference -0.1, 95% confidence interval -0.4 to 0.2, P = 0.6) or physical function (-0.1, -0.4 to 0.2, P = 0.5), despite a decreased risk of ectopic bone formation (relative risk 0.69, 0.56 to 0.83) associated with ibuprofen. There was a significantly increased risk of major bleeding complications in the ibuprofen group during the admission period (2.09, 1.00 to 4.39).<b><br />Conclusions </b>These data do not support the use of routine prophylaxis with NSAIDs in patients undergoing total hip replacement surgery.<br /><b>Trial registration </b>NCT00145730.<br />